Nasal Reconstruction Using a Customized 3D-printed Nasal Stent for Congenital Arhinia

September 23, 2015 updated by: Jong-Won Rhie MD.PhD, Seoul St. Mary's Hospital
A 7-year-old arhinia patient receives nasal reconstruction with nasal cavity reconstruction and is aided with the application of a 3D-printed nasal stent to prevent nasal cavity constriction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After reconstruction of a nasal cavity in the maxilla by burring using a navigation system, the patient required a nasal stent to prevent stenosis. However there was no conventional stent available. A 3D-printed silicone nasal stent was custom made for the cavity and inserted.

Study Type

Observational

Enrollment (Actual)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

A 7-year-old male patient with congenital arhinia with no history of previous treatment.

Description

Inclusion Criteria:

  • Single patient
  • 7-year-old male
  • Congenital arhinia
  • No history of previous treatment

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal cavity diameter
Time Frame: 6 months
Change from baseline nasal cavity diameter (measured by CT sagittal section, in millimeters)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Collaborators

Pohang University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 26, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • SM-AR-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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